Definition Compliance vs. Registration - What is the difference?

K

KHAN786

#1
#1
Compliance vs. Registration - What is the difference? I.E WHAT IS MEANT BY U HAVE TO BE WORKING TOWARDS COMPLIANCE OR REGISTERATION
 
Download Free White Paper
Elsmar Forum Sponsor
T

Tom Goetzinger

#2
#2
Typically, "compliance" indicates that YOU say you meet the requiremens of the standard. "Registration" means that an approved third party registrar has audited you and certified that you meet the requirements of the standard.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D Compliance to 21 CFR Part 11 Require Registration to FDA? Qualification and Validation (including 21 CFR Part 11) 9
Q FDA Establishment Registration - Does registration require compliance to the QSR? ISO 13485:2016 - Medical Device Quality Management Systems 8
R Evidence of compliance with Directive 2013/59/Euratom EU Medical Device Regulations 3
T Electronic Systems and 8.5.2 compliance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Sidney Vianna ISO 37301 - Compliance management systems – Requirements with guidance for use Other ISO and International Standards and European Regulations 0
H Regarding compliance according WEEE Directive CE Marking (Conformité Européene) / CB Scheme 6
M Regulatory compliance ISO 14001 ISO 14001:2015 Specific Discussions 5
S Requirements for ANSI Z540.3 Compliance as End User of Calibrated Instruments AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
M How to build a winning strategy for EU MDR Compliance Book, Video, Blog and Web Site Reviews and Recommendations 0
A Compliance with iso 14155 Other Medical Device Related Standards 1
T Determining FIPS 140-2 compliance in a medical device Medical Information Technology, Medical Software and Health Informatics 2
C Deadline for compliance with added MDR harmonized standards CE Marking (Conformité Européene) / CB Scheme 2
I User ID verification for in-house e-signature compliance Qualification and Validation (including 21 CFR Part 11) 2
Ron Rompen 4.4.1.2 Product Safety Compliance IATF 16949 - Automotive Quality Systems Standard 29
W 6.1.3 Compliance obligations b) - problem with understanding ISO 14001:2015 Specific Discussions 0
S Question: Best alternatives to audits for ensuring compliance Quality Tools, Improvement and Analysis 5
K Compliance Obligations 6.1.3 of ISO 14001 ISO 14001:2015 Specific Discussions 3
Ed Panek Which choice of the following most closely matches the MDR compliance of your company? EU Medical Device Regulations 0
G IEC 60601 Compliance IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Proof QMS compliance for class I ISO 13485:2016 - Medical Device Quality Management Systems 1
G Compliance with ISO 9001-2015 for ISO 17025 Accredited Labs? ISO 17025 related Discussions 5
L REACH compliance with MDR EU Medical Device Regulations 4
K ROHs compliance requirement REACH and RoHS Conversations 10
Z Choice of PTC heater voltage to maximize user safety and ease of CE compliance to LVD CE Marking (Conformité Européene) / CB Scheme 0
Z REACH compliance for low volume product REACH and RoHS Conversations 1
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
E Accredited vs. non-accredited labs for 60601 compliance in the US IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Accredited vs. non-accredited labs for 60601 compliance in the US Other Medical Device Related Standards 4
M Class II type machine , and its compliance with 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
Cats Clause ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
H Automotive wires - Compliance with USCAR21-4 & USCAR38-1 Various Other Specifications, Standards, and related Requirements 1
M FULFILMENT of compliance obligation versus COMPLY with compliance obligations ISO 14001:2015 Specific Discussions 2
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 2
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 12
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
D HIPAA, HITECH and Interoperability compliance route Medical Device and FDA Regulations and Standards News 2
armani Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
M Tracking Expiration dates on compliance certifications REACH and RoHS Conversations 2
T Training recommendations? Bringing our RoHS and REACH compliance efforts in-house REACH and RoHS Conversations 2
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
G ISO 14001 - 6.1.3 Compliance Obligations ISO 14001:2015 Specific Discussions 1
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 11
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 25

Similar threads

Top Bottom